Magseed Enabled Long-Term Localization of Axillary Lymph Nodes

Part of paid clinical trials in Houston, Texas.

Sponsor
Endomagnetics Ltd.
Study ID
NCT03796559
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Magseed Marker — DEVICE
    Implantable Magseed marker for marking lesions in soft tissue, detected using the Sentimag handheld probe.

Study Details

The purpose of this study is to provide prospective evidence that the use of Magseed/Sentimag in marking axillary lymph nodes and guiding surgical localization in patients with breast cancer following neo-adjuvant chemotherapy (NAC) is effective.

Key Dates

Start date
Jun 13, 2019
Status verified
Aug 2024
Primary completion
Feb 28, 2026
Completion
May 31, 2026

Study Design

Enrollment
65 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Magseed marker
    Magseed marker deployed percutaneously, prior to patient undergoing neo-adjuvant chemotherapy (NAC), under ultrasound guidance to mark a lymph node intended for selective surgical removal post NAC.

Primary Outcome Measure

Retrieval rate of clipped node and Magseed in the excised specimen [ Time Frame: Time of surgery ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Baylor MedicineHoustonTexas77030
MD Anderson Cancer CenterHoustonTexas77030
Veronika Noregil
Kelly Hunt, MD, F.A.C.S.

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